Category: Compliance

HHS Attorney Advises to Expect More Aggressive HIPAA Enforcement

Jerome Meites, a chief regional civil rights counsel for the U.S. Department of Health and Human Services (“HHS”), provided important insight into upcoming HIPAA enforcement at the recent American Bar Association conference in Chicago .  Since June 2013, over $10 million has been paid by entities to settle alleged HIPAA violations.  Mr. Meites predicted that, […]

Explosion of Big Data: What the Release of CMS Medicare and Sunshine Payment Data Means for Industry

The Centers for Medicare & Medicaid Services (CMS) released this month the 2012 Medicare payment data for individual physicians.  CMS also recently wrapped up its Phase I collection of data related to payments and transfers of value from pharmaceutical, medical device and biotechnology manufacturers and group purchasing organizations to physicians […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]